The present invention relates to the field of medical devices. In particular, the present invention relates to a method and device for removing fluids, tissue and other debris from an inner lumen or chamber of a tubular member of a medical device. In addition, the present invention relates to a method and device for introducing a guide wire into an inner lumen of a tubular member of a medical device.
There are numerous medical procedures that involve inserting tubular members within the body of the patient. In particular, a typical angioplasty procedure requires inserting at least a guide catheter and a dilatation catheter into the vascular system of a patient to open a stenosis within that vascular system. One type of dilatation catheter is an over-the-wire catheter. The standard over-the-wire catheter has an inner or guide wire lumen that extends from the distal end of the catheter to the proximal end of the catheter. A manifold is attached at the proximal end of the catheter to provide an attachment for fluid communication with the guide wire lumen.
A single operator exchange catheter, or S.O.E. catheter, is a variation of the over-the-wire catheter. The S.O.E. catheter has a guide wire lumen that only extends through a portion of the catheter. The guide wire lumen extends from the distal end of the catheter to a distal porthole on the catheter tube.
The guide wire lumen is provided on a standard over-the-wire catheter and an S.O.E. catheter so that a guide wire can be used to establish a path through the vascular system to the stenosis of the patient. The use of the guide wire enables the catheter to be advanced through the blood vessel relatively quickly, thereby reducing the time required for the procedure. In some angioplasty procedures, it may be desirable to use dilatating catheters having different balloon sizes or configurations. Therefore, it is common for the operator to remove a catheter from the vascular system and set that catheter aside to be reinserted at a later time in the procedure.
One concern that arises when the operator attempts to reinsert the catheter into the vascular system relates to the fact that the inner or guide wire lumen of the catheter was in fluid communication with the vascular system of the patient. Therefore, blood and other tissues from the patient may have collected within the guide wire lumen of the catheter. Such blood and tissue may coagulate and block the guide wire lumen of the catheter when the catheter is removed from the vascular system. The coagulated tissue then makes the catheter inoperable, since it prevents the operator from effectively guiding the catheter over the guide wire. Accordingly, the operator must flush the inner lumen of the catheter after removing it from the patient if the operator wants to reinsert the catheter later during the procedure.
The flushing procedure for a standard over-the-wire catheter is relatively simple because a luer-fitting is attached to the manifold on the proximal end of the guide wire lumen. The operator can simply attach a standard syringe to the proximal end of the guide wire lumen and force flushing fluid through the lumen. The flushing procedure for an S.O.E. catheter is more difficult to perform because there is no fitting on either end of the guide wire lumen to connect a syringe to the guide wire lumen.
The standard technique for flushing the inner lumen of an S.O.E. catheter involves inserting a blunt needle into the guide wire lumen of the catheter to provide a means for fluid communication between the guide wire lumen and a syringe connected to the blunt needle. This procedure is inherently difficult to perform and is potentially dangerous. The guide wire lumen of an angioplasty catheter is generally very small in size. For example, an angioplasty dilatation catheter having a guide wire lumen with a diameter as small as 0.016 inches is common in the medical industry. Therefore, it is very difficult to insert a lumen flushing needle (which commonly has an outside diameter of 0.012 inches) within the guide wire lumen of such a catheter. This problem is magnified by the fact that an angioplasty procedure is generally performed in a darkened room, making it very difficult to see the guide wire lumen of the catheter and the needle.
This procedure also creates a situation that is inherently dangerous to the operator. It is extremely easy for the operator to accidently stick a finger while attempting to insert the needle into the lumen ("needle stick"). Such an accident exposes the operator to a potential inadvertent transfer of dangerous or fatal diseases.
There are also numerous medical procedures besides angioplasty that require an operator to use a lumen flushing technique similar to that described above. For example, some tissue collection procedures present the need for removing tissues from a collection chamber to perform further pathological studies on the tissue. It would be advantageous to provide an efficient and effective means to flush the inner lumen of certain medical devices without exposing the operator to the inherent dangers of the current needle-based method.
Another concern that arises during an angioplasty procedure occurs when the operator attempts to load the guide wire into the catheter while the guide wire is in the vascular system of the patient. Generally, the relative diameters of the guide wire and the guide wire lumen make it difficult for the operator to load the guide wire into the inner or guide wire lumen. Once again, this problem is magnified by the fact that the angioplasty procedure is generally performed in a darkened room. This basic problem of loading a guide wire into the guide wire lumen increases the time it takes to exchange a catheter, thereby increasing the time of the procedure. Therefore, it would be advantageous to provide an efficient and quick means to load the guide wire into the guide wire lumen of an angioplasty catheter.